Generics Bulletin is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Industry Not Sold On FDA Emerging Technology Program

Complaints Voiced About Cost And Value of Investment

Executive Summary

FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at a recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.

You may also be interested in...



FDA Continuous Manufacturing Guidance Raises Concerns About Scope And Cost

Makers of brand pharmaceuticals focused on scope issues and the definition of terms in their comments on the US FDA's draft continuous manufacturing guidance, while makers of generic drugs raised concerns about cost and lack of benefit.

FDA Invites Comment On Continuous Manufacturing

Draft guidance on quality considerations for continuous manufacturing has been published by the US Food and Drug Administration with a 90-day comment period.

FDA Reports Growing Use Of Process Modeling Tools To Support Continuous Manufacturing

FDA reports “growing traction” of continuous manufacturing and a corresponding uptick in the use of models to support this mode of manufacturing. Officials explain how they assess these models during inspections.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

GB149378

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel